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NEWS
Vertex pivotal trial
Vertex has announced that its Phase
1/2 trial for its VX-880 stem cellderived
islet therapy is converting to
a Phase 1/2/3 pivotal trial, enrolling
50 total people. This is the first time
that a scalable cure for some people
with Type 1 diabetes has entered a
Phase 3 clinical trial.
Cell therapies such as Vertex's VX880 aim to make
insulin-producing
cells and safely put them inside the
body to replace cells that have been
lost. VX-880 uses stem cell-derived
islets, which primarily contain beta
cells, to restore the body's ability to
produce insulin.
VX-880 is not suited for the entire
T1D community: it is currently only
being tested in people with T1D with
severe hypoglycaemia unawareness
and significant hypoglycaemic
episodes. Nevertheless, the data
on how this therapy is working
is exciting. All of the participants
who have received the full dose of
the therapy are showing benefits,
including: insulin production, the
elimination of severe hypoglycaemia
and significantly improved glucose
control. Indeed, 11 out of the 12
participants have reduced or
eliminated the need for external
insulin.
However, a new therapy must
undergo a series of clinical trials to
assess its safety and efficacy before
receiving FDA approval, with the
last stage usually being a Phase 3, or
pivotal trial, which gathers the data
required for an FDA submission.
Read more, CLICK HERE.
Humans and carbs
Trying to reduce your carbohydrate
intake means going against nearly a
million years of evolution.
Humans are among a few species
with multiple copies of certain genes
that help us break down starch -
carbs like potatoes, beans, corn, and
grains - so that we can turn it into
energy our bodies can use. However,
it's been difficult for researchers to
pinpoint when in human history we
acquired multiple copies of these
genes because they're in a region of
the genome that's hard to sequence.
A recent study suggests that humans
may have developed multiple copies
of the gene for amylase - an enzyme
that's the first step in starch digestion
- over 800,000 years ago, long
before the agricultural revolution.
This genetic change could have
helped us adapt to eating starchy
foods.
However, this adaptation has
become a double-edged sword:
on the one hand, the human body
needs and craves carbs to function.
On the other hand, our modern-day
consumption of carbs, especially
calorie-dense/nutritionally-barren
processed carbs, has long since
passed 'healthy'.
Overall, this research adds to the
growing evidence that humans have
a long history of loving carbs - for
better and, at least over our most
recent history and immediate future,
for worse.
Read more, CLICK HERE.
Fish skin and DFUs
Recent research has found that intact
fish skin grafts, sourced from Atlantic
cod, show superior and faster healing
than standard wound care practices
in patients with deep and penetrating
diabetic foot ulcers.
Standard wound care for diabetic
foot ulcers involves vascular
assessment, surgical debridement,
use of appropriate dressings,
infection management, and glycaemic
control; however, this is typically
associated with poor outcomes.
Researchers conducted a clinical
trial across France, Italy, Germany,
and Sweden to evaluate using intact
fish skin grafts to treat complex
diabetic foot ulcers. A total of 255
patients with diabetes and lower limb
wounds penetrating to the tendon,
capsule, bone, or joint were randomly
assigned to receive either an intact
fish skin graft or standard wound
care for 14 weeks.
The research found that the
proportion of wounds healed at 16
weeks was higher with intact fish
skin grafts (44.0%) than with standard
wound care (26.4%) and the fish skin
grafts continued to be more effective
than standard wound care practices
at 20 and 24 weeks.
To find out more, CLICK HERE.